To implement new accreditation programs and activities in real time and with more focused attention, the CAP has expanded the Commission on Laboratory Accreditation to include two new committees and enlarged five others from a one-person shop to four or five members. It also created a new overarching Council on Accreditation to which the commission will report.

The new committees are Continuous Compliance, which will evaluate measurements that will help judge the risk of a laboratory falling out of compliance with CAP standards between inspections; and Inspection Process, which will examine how inspections are conducted, including implementing and monitoring the new unannounced inspections (Related article: Surprise!
Unannounced inspections not so bad). The Accreditation, Complaints, Accreditation Education, Checklists, and Safety committees will play roles previously handled by a single commissioner.

R. Bruce Williams, MD, chair of the Commission on Laboratory Accreditation, says the commission previously had reported to the CAP Council on Scientific Affairs. “We’ve been looking for ways to better implement new programs and to further the accreditation process on a more timely basis,” he says. “The Board [of Governors] felt that the inspection and accreditation process was such a significant part of the College that it would be good if there was a council created to have direct oversight of the accreditation process.”

The commission will oversee, review, and make policy to ensure that the process
runs as smoothly as possible, Dr. Williams says. “The commission will continue
to be the folks that look at or deal with the day-to-day activities of making
sure the inspection and accreditation program runs efficiently,” he says. “The
council thought that...we could give closer oversight and better direction
if the commissioners were more permanently assigned to oversee specific areas
of the accreditation program.”

Stephen Bauer, MD, chair of the new Council on Accreditation, says the CAP has reorganized the commission to focus attention on areas that need to be improved. “The commission is a relatively large structure,” he says. “It’s difficult for them to stay focused on a large number of projects and keep them all prioritized. We broke the commission down into committees that would have specific areas of responsibility.”

The Continuous Compliance Committee will spot-check to make sure there aren’t laboratories falling out of compliance between inspections that the CAP would want to check more thoroughly, Dr. Williams says.

“The most obvious way [to do so] is through review of proficiency tests,” he
says. “Those laboratories that repeatedly fail their proficiency may need to
be more closely evaluated.... The committee is in charge of proficiency testing
and evaluation to ensure that everyone’s performing up to speed.”

Dr. Bauer says the CAP has had a couple of experiences where state governments have come in after College inspections and found deficiencies. “We asked ourselves, ‘How do we know between inspections whether a laboratory is still in compliance?’” he says. “We wanted to have more of a comfort level.”

The commission drew up a list of about 50 possible warning signs that further investigation might be needed, Dr. Bauer says. “The goal is to be able to identify those laboratories between inspection cycles, take a look at the laboratory, ask whether we need to contact them for more information, and have someone do a re-inspection, so we don’t get caught flat-footed if CMS comes in and looks at a lab.”

Inspecting laboratories once every two years with some monitoring of proficiency testing in between has not led to close enough oversight, says Chantal R. Harrison, MD, who chairs the new Continuous Compliance Committee.

“The idea was to have a specific committee assigned to developing new methods
to ensure continuous compliance, so that laboratories are not in compliance
every two years but all the time,” she says. “How can we identify a laboratory
that might be at high risk of not being in compliance, and how do we deal with
it? Do we recommend a nonroutine inspection?... How can we identify laboratories
that are repeatedly failing proficiency testing, and what do we do about it?”

The committee also will look at alternative proficiency testing programs for labs that do not have access to CAP-approved programs, Dr. Harrison adds. “International labs, for example, might have difficulty finding external proficiency testing.”

The other new committee, Inspection Process, will examine all components of the process, Dr. Williams says. “From the application, all the way through the assigning of the inspection team, the pre-inspection packet, the actual inspection process—how it goes during the day—and then the post-inspection process, for the review of the deficiencies found during the inspection.”

The CAP will continue to use checklists to help inspectors and laboratories structure the experience, Dr. Bauer says, but the Inspection Process Committee will explore what can be done to augment those findings.

“It’s a great summary of what laboratories ought to do,” he says of the checklists. “The problem is, it’s so lengthy that it’s very difficult for an inspection team to thoroughly go through those questions and look at the documentation for everything. We would like this committee to look at tools other than the inspection checklist to make sure we find the things we ought to be finding.”

In doing so, Dr. Bauer expects inspectors will be spending more time talking
to bench technologists, as opposed to relying solely on procedure manuals and
lab supervisors. “We’ve asked this group to look at the inspection process
itself, take it apart, find out what we know from our best inspectors...and
see if we can develop different methods,” he says.

C. Robert Baisden, MD, chair of the Inspection Process Committee, says there is a “heightened focus on critical issues.”

“We are focusing on the handling of specimens, QC, QA, safety for patients and employees, test methods, instrument operations, and the postanalytic handling of patient test data. We are teaching our inspectors to look for critical issues and to drill down on the issue and look for the problem. Of course, the lab will not be accredited until the problem is corrected.”

The Accreditation Committee, chaired by Robert Rickert, MD, has been established as a separate committee apart from the commission that will report directly to the council, Dr. Williams says. That’s being done to lessen the perception of conflict of interest between those who design, set up, and evaluate the accreditation process and those who make the actual accreditation decisions, he says. “This will be an independent group,” Dr. Williams says, “and they will make all decisions concerning the accreditation status of a laboratory.” That includes whether to grant routine accreditation or whether the lab should be accredited with conditions, put on probation, suspended, or have its accreditation revoked.

Dr. Bauer says decisions previously had been handled by an individual commissioner
unless problems arose, in which case the chair of the commission examined the
cases. “The decisions they’re making are so important, we felt this needed
to be a totally separate, independent group,” he says. “We didn’t want them
biased by other operations.... By having a committee handling it, we have more
of an opportunity to have a discussion, and we’re not as vulnerable if anything
were to happen to the one person.”

The Complaints Committee, chaired by Gerald Hoeltge, MD, will take over a function previously handled by Dr. Hoeltge alone and, it is hoped, boost the CAP’s visibility in that area, Dr. Williams says. “It could be a complaint from a patient or a laboratory employee,” he says. “It could be a complaint generated from an adverse news event or by another accrediting agency such as JCAHO. That committee will be charged with evaluating all complaints.”

Dr. Bauer says the number of complaints generated has doubled since the CAP posted a notice for its complaints hotline. “This just got to be too big of a job for one person,” he says.

The Accreditation Education Committee, chaired by Francis Sharkey, MD, will develop and implement the Web and printed materials, audioconferences, inspector training workshops, and other educational components of the accreditation program.

“In order for the College to perform reliable and accurate inspections, it is important that both the team leaders and the team members be educated in the correct manner to perform an inspection,” Dr. Williams says. That will be required first for team leaders and later for all team members, he adds.

“We’re beefing up the education for our team leaders and our team members,” Dr. Bauer says, noting that a single commissioner, Dr. Sharkey, had handled this area. “With the added emphasis we’re giving to education now, we wanted a group of people working on this.”

The Checklists Committee, chaired by Stephen Sarewitz, MD, who alone was in charge of checklists previously, will oversee the creation of and updates to the various checklists, Dr. Williams says. And the Safety Committee, a subcommittee of the Checklists Committee and one that Dr. Baisden will chair, will evaluate the safety requirements of accreditation.

Tying all these strands together will be the Executive Committee of the Commission on Laboratory Accreditation. Composed of all of the committee chairs, the executive committee will oversee the accreditation process between commission meetings, he says. It also will ensure the other committees work together smoothly, Dr. Bauer adds, and handle any issue that doesn’t fall under another committee’s purview.